XSpray Pharma AB confirmed on Thursday that it has re-submitted its application to the U.S. Food and Drug Administration for Dasynoc. The company said it has worked to address regulatory matters cited previously and has now filed an updated application for review.
In a statement, XSpray said it expects the FDA to assign a new Prescription Drug User Fee Act - PDUFA - date by August 2026 at the latest. The PDUFA date establishes the FDA's formal deadline for completing its review of the drug application.
Alongside the resubmission news, the Swedish drugmaker reiterated its commercial timeline, maintaining plans to launch two products in the second half of 2026. Those planned launches are Dasynoc and XS003 nilotinib, both intended for the U.S. market and positioned within XSpray's oncology-focused portfolio.
Dasynoc is described by the company as a candidate intended to serve as an alternative treatment option. The resubmission follows a period during which XSpray worked to meet regulatory requirements identified in earlier interactions with the FDA.
XS003 nilotinib is identified as the second product in the company's U.S. development pipeline. XSpray framed both assets as part of its focus on oncology therapies for the U.S. market.
Context and next steps
The company is now awaiting an official PDUFA date from the FDA, which will set the agency's internal target for completing its review of the Dasynoc application. XSpray has not provided additional dates beyond the statement that August 2026 is the latest expected PDUFA assignment.
Management has kept its previously announced goal of introducing two products in the latter half of 2026, signaling continued focus on regulatory progress and product launches for its oncology portfolio.
Summary of announcements
- Dasynoc resubmitted to the U.S. FDA.
- Company expects a PDUFA date to be set by August 2026 at the latest.
- XSpray maintains plans to launch Dasynoc and XS003 nilotinib in the second half of 2026.